- Merck & Co. (Rahway, NJ)
- …, is responsible for independent approval of documentation to support GMP clinical supply drug product manufacture, testing, release, and maintenance in support ... of our company's clinical supply programs. This person will also independently approve documentation accompanying the disposition of excipients, components, and… more
- Insmed Incorporated (NJ)
- …what's possible for patients with serious diseases. Reporting to the SVP, Technical Operations , you will lead all Chemistry, Manufacturing, and Controls (CMC) ... will serve as a key member of the Technical Operations leadership team and contribute significantly to our overall... leadership team and contribute significantly to our overall product development strategy.You'll lead both drug substance… more
- Insmed Incorporated (NJ)
- …what's possible for patients with serious diseases. Reporting to the SVP, Technical Operations , you will lead our gene therapy and large molecules pipeline ... are seeking a highly experienced and visionary Vice President, Product Development - CMC, Gene Therapy and Large Molecules,...you will be a key member of the Technical Operations leadership team and play a critical role in… more
- Merck & Co. (Rahway, NJ)
- …Grade: Senior / R5-equivalent - About the role We are hiring a Senior Product Manager to lead strategic development of our Integrated Printing and Plastic ... primary point of contact for manufacturing leadership, engineering, commercial teams, supply chain, quality, IT, and external partners/vendors. Lead stakeholder… more
- Novo Nordisk Inc. (Boulder, CO)
- …Essential Functions Lead , manage, and advise all aspects of drug product manufacturing operations at CMOs to manufacture clinical parenteral medicines ... The position will manage CMO's to ensure the continuous supply of product and apply risk mitigation...in a laboratory setting as needed. This position will lead a team of Drug Product Managers… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in a collaborative team setting with quality counterparts that include Manufacturing Operations , Operations Technical Support, Maintenance, Supply Chain and ... treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based...occur in the production of a personalized cell therapy product in a sterile GMP environment. The ideal candidate… more
- Merck & Co. (Durham, NC)
- …performance metrics (Schedule Adherence, Release on Time, Customer service performance, Product Lead Time, etc.)Continuous Improvement - Accountable for ... Job DescriptionOur Manufacturing Operations teams are the people that make therapies...substances, drug products, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse.-The ideal candidate for this… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Operations Process Trainer as part of the Technical Operations team based ... Process Trainer will be responsible for performing process training activities for Operations team members who support cGMP Clinical and Commercial Cell Therapy… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and tracking of quality metrics while ensuring high quality and complaint product supply .Key Responsibilities Support compliance activities for site Quality ... in a collaborative team setting with quality counterparts that include Manufacturing Operations , Operations Technical Support, Maintenance, Supply Chain and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... scientific engagement and communication- Serves as Global Medical Affairs Team (GMAT) Lead , to gain strategic and planning alignment across the matrix team… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of Excellence ... packaging components and packaging master data and systems.The Packaging Technical Operations organization aims to be an industry leader in problem-solving,… more
- Merck & Co. (Rahway, NJ)
- …support for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally.-The Packaging Technical Operations organization ... solvingStrong technical writing and project management capabilities.Understanding of new product introduction, commercial supply , lifecycle management.Proven track… more
- Merck & Co. (Rahway, NJ)
- …Drug Product and Finished Goods globally.- The Packaging Technical Operations organization aims to be an industry leader in problem-solving, delivering robust ... the commercialization of new products, and ensuring an uninterrupted, compliant supply of commercialized products for the benefit of patients. The Logistics… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …other functions including but not limited to Tech Support, Process Improvement, Validation, Supply Chain, Operations , QA, Reg CMC, and IT. This individual will ... and Technology team reporting to the Manufacturing Execution Systems Lead and will be responsible for providing project management...enable robust EBR and IT solutions for production of product to patients. This individual will also be responsible… more
- Merck & Co. (Durham, NC)
- …Deviation Management, Manufacturing Technical Operations , Validation, New Product Technical Transfer Departments, Supply Chain Management, Quality, ... Process Control, Process Optimization, Process Scale Up, Production Management, Production Operations , Quality Management, Supply Change Management {+ 2… more
- Insmed Incorporated (NJ)
- …we're in. Are you?About the Role:The role is a member of the Global Supply Chain & Logistics - Supplier Relationship Management team supporting the Technical ... Operations organization. The role will partner closely with Commercial...The role will partner closely with Commercial and Clinical Supply Chain with responsibilities including supplier governance management, understanding… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Finance & Operations department brings insights and intelligence to inform decision making & drives digitalization and business solutions to ... attain NNI goals. Finance & Operations works closely across the organization to guide enterprise-wide resource allocations, investment choices, drive core … more
- Insmed Incorporated (NJ)
- …messaging, and go-to-market frameworks tailored to HCPs treating fibrosing ILDs. Lead campaign development to engage pulmonologists, ILD specialists, and community ... Medical Affairs to ensure scientific and clinical insights inform HCP strategies. Lead development and implementation of tactical plans for health care… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... of successful Health Authority inspections and approvals - Proactively partner and lead the strategic collaboration with other GxP Quality representatives, and act… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …other functions including but not limited to Tech Support, Process Improvement, Validation, Supply Chain, Operations , QA, Reg CMC, and IT. This individual will ... of MSAT team reporting to the Manufacturing Execution Systems Lead and will be responsible for interfacing with MES...responsible for gaining the necessary process knowledge of the product and system knowledge of PAS-X to develop EBR… more
